Trial · NCT03358017
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proof of concept primary activity endpoint - Efficacy endpoint | At surgery, after 6 months of study treatment | Relative reductions of YAP and TAZ IHC-expression at surgery with respect to core-biopsy analysis. |
| Primary | The proportion of responded patients | After 6 months of study treatment | The clinical primary activity endpoint of the second phase of study is the proportion of responder patients, defined as those obtaining a pCR, defined as ypT0ypN0 or as the absence of any residual tumor burden at surgery. |
| Secondary | In relation to high/low p53 levels, relative reductions of YAP and TAZ IHC-expression at surgery with respect to core-biopsy analysis. Efficacy endpoint | At surgery, after 6 months of study treatment | Relative reductions of YAP and TAZ IHC-expression at surgery with respect to core-biopsy analysis according to high/low p53 levels. A high level of p53 is defined by IHC expression ≥30%, while a low level by IHC expression \<30%, as previously described |
| Secondary | Proportion of responder patients according to high/low p53 levels - Efficacy endpoint | After 6 months of study treatment | Proportion of responder patients according to high/low p53 levels |
| Secondary | Disease Free Survival (DFS) - Efficacy endpoint | Date of first recurrence or relapse, second cancer, or death, whichever came first, assessed up to 36 months | Disease free survival (DFS), defined as the time from the date of treatment start to the first of either recurrence or relapse, second cancer, or death, whichever comes first. Subjects alive not having relapse or recurrence or second cancer by the end of the study will be censored at the last disease assessment date. |
| Secondary | Overall survival - Efficacy endpoint | Date of death from any cause, assessed up to 36 months | Overall survival (OS), calculated for each patient as the time from the date of treatment start to the date of death from any cause. Patients not reported as having died at the end of the study will be censored at the date they were last known to be alive. |
| Secondary | Regulation of YAP and TAZ gene expression by RNA-Seq in tumor tissue - Efficacy endpoint | At surgery, after 6 months of study treatment | Proportions of patients with down regulation of YAP and TAZ gene expression by RNA-Seq in tumour tissue collected at definitive surgery with respect to tumour tissue collected at the time of core-biopsy for responder and non-responders patients. |
| Secondary | Relative reduction of Ki67 in tumor samples - Efficacy endpoint | At surgery, after 6 months of study treatment | Relative reduction of Ki67 IHC expression in tumour tissue samples collected at definitive surgery with respect to tumour tissue collected at the time of diagnostic core-biopsy for responder and non-responders patients. |
| Secondary | Study treatment safety - Safety endpoint - AE | From the date of randomization/registration to the end of study, up to 36 months | In order to address the safety endpoint the study will evaluate: \- Incidence, nature, severity and seriousness of AEs, according of National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 |
| Secondary | Study treatment safety - Safety endpoint - Maximum grade | From the date of randomization/registration to the end of study, up to 36 months | In order to address the safety endpoint the study will evaluate: \- Maximum toxicity grade experienced by each patient for each specific toxicity |
| Secondary | Study treatment safety - Safety endpoint - Percentage | From the date of randomization/registration to the end of study, up to 36 months | In order to address the safety endpoint the study will evaluate: * Percentage of patients experiencing grade 3-4 toxicity for each specific toxicity * Percentage of patients with at least one SAE * Percentage of patients with at least one serious adverse drug reaction (SADR) * Percentage of patients with at least one suspect unexpected serious adverse reaction |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT03358017/registered